effects of chantix on relapse prevention for smoking cessation

Conditions: Nicotine Dependence

Summary: the goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

the proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. a positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. in addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.

Eligibility criteria:
inclusion criteria: * eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline co reading ≥ 10 ppm and who plan to live in the area for the next 6-months. exclusion criteria: * smoking behavior 1. use of chewing tobacco or snuff 2. current enrollment or plans to enroll in another smoking cessation program in the next 5 months 3. plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months 4. provide a baseline co reading \< 10 ppm alcohol/drug exclusion criteria 1. history of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants) 2. current alcohol consumption that exceeds \>25 standard drinks/week medication exclusion criteria 1. current use or recent discontinuation (within last 14-days) of the following medications: 1. any form of smoking cessation medication (zyban, wellbutrin, wellbutrin sr, chantix, nrt) 2. any form of anti-psychotic medications that includes: * antipsychotics, * atypical antipsychotics, * mood-stabilizers, * anti-depressants (tricyclics, ssri's, maoi's), * anti-panic agents, * anti-obsessive agents, * anti-anxiety agents, and * stimulants (e.g., provigil, ritalin). 3. medication for chronic pain 4. anti-coagulants 5. any heart medications 6. daily medication for asthma medical exclusion criteria 1. women who are pregnant, planning a pregnancy, or lactating. 2. history or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any axis 1 disorder as identified by the scid. 3. serious or unstable disease within the past 6 months (e.g., cancer \[except melanoma\], heart disease, hiv). 4. history of epilepsy or a seizure disorder. 5. history or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (\>100 beats/minute); history or current diagnosis of copd, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (sbp\>150 or dbp\>90) 6. history of kidney and/or liver failure (including transplant). 7. wears a device to aid in hearing (hearing aid, cochlear implant, etc.). 8. hearing threshold \< 40 db spl at 1000 hz. 9. color blindness. general exclusion 1. any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician. 2. inability to provide informed consent or complete any of the study tasks as determined by the principal investigator and/or study physician. 3. any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.

Keywords: varenicline, working memory